Combination of Oral and Topical Whitening Agents for Reducing Skin Pigmentation in Healthy Women: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Skin spots assessment
Study Overview
Brief Summary
The goal of this study is to evaluate the safety and efficacy of a combination use of oral supplement and topical serum in improving skin pigmentation in healthy women. The main questions it aims to answer are:
Does combination use able to reduce the dark spot? Is there any adverse effect associate with the product use?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy Malaysian women.
- •Aged 30 - 60 years old.
- •Fitzpatrick skin type III-V
- •Exhibiting signs of skin pigmentation such as post-inflammatory hyperpigmentation, freckles and solar lentigines.
Exclusion Criteria
- •Participants with melasma.
- •Pregnant, breastfeeding women, or those planning pregnancy during the study period.
- •Participants with documented chronic medical conditions such as kidney disease, diabetes, heart problems, liver disease, gastrointestinal disorders, and others.
- •Participants with documented autoimmune diseases.
- •Participants with inflammatory or allergic skin problems such as atopic dermatitis, rosacea, or psoriasis.
- •Use of topical agents for skin brightening within the past three months.
- •Consumption of food or supplement products containing L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, pine bark extract, or other similar supplements, as well as the use of topical products containing niacinamide, glycyrrhiza glabra (licorice) root extract, retinol, or other products for skin brightening or rejuvenation within three months prior to the study.
- •Undergoing any cosmetic procedures such as botox, laser and light treatment, facial surgery, or any procedures aimed at improving skin conditions (e.g., skin brightening, elasticity, wrinkles, pores) prior to the study.
- •Consumption of any medical or hormonal treatments that could interfere with the study results, such as isotretinoin, tranexamic acid, and others.
- •Allergy to any ingredients that may be found in the product.
Arms & Interventions
Oral supplement + Retinol serum
Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.
Intervention: oral supplement (Dietary Supplement)
Oral supplement + Retinol serum
Oral supplement is the same as the other arm. Topical serum containing niacinamide, glycyrrhiza glabra (licorice) root extract, and retinol.
Intervention: Retinol serum (Other)
Oral supplement
Oral supplement contain L-glutathione, L-cysteine HCL monohydrate, polypodium leucotomos leaf extract, and pine bark extract.
Intervention: oral supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Skin spots assessment
Time Frame: Baseline, Week 6, Week 12
Changes in skin spots (assessed under polarized and UV light) are evaluated using the JANUS III Facial Skin Analysis System.
Skin brightening assessment
Time Frame: Baseline, Week 6, Week 12
Changes in skin brightness (L value) are evaluated using the JANUS III Facial Skin Analysis System.
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](12 weeks)
- Participants satisfaction(Week6, Week12)